#edurant

ViiV first applied for FDA approval of Cabenuva in April 2019.

“HIV and Zika virus are distinct types of RNA viruses,” said Kamel Khalil, PhD, one of the researchers at Temple, in a press release, meaning the viruses carry their genetic code in single-stranded RNA, as opposed to double-stranded DNA.

Publishing their findings in HIV Medicine, researchers conducted a multicenter, prospective and observational study of 1,490 people with HIV who started their first antiretroviral (ARV) treatment with Edurant (786 people) or Sustiva (704 people) and were members of the Italian Cohort Native Antiretrovirals Foundation Study. All participants began the study with a viral load below 100,000.

For the first time, the U.S. Food and Drug Administration (FDA) has approved an HIV treatment regimen that contains only two antiretrovirals (ARVs), instead of the standard three or more drugs. Juluca (dolutegravir/rilpivirine), a combination of drugs from ViiV Healthcare and Janssen, is approved as a new option for people with HIV who have been virally suppressed on their current ARV regimen for at least six months.

The ATLAS study is a Phase III open-label, active-controlled multicenter parallel group noninferiority trial including 618 adults living with HIV in various countries around the world, including the United States. The participants all had fully suppressed HIV for at least six months upon entering the trial, at which point they were taking a daily oral regimen including two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus an additional oral ARV. Their oral regimen needed to have been either their first or second since first starting treatment for the virus.

Forty-eight week results from the replicate 148-week randomized open-label noninferiority SWORD 1 and 2 studies were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle and later published in The Lancet.

Your doctor is right that it’s theoretical in that it hasn’t been specifically reported, but it would still make me nervous. I would worry that going 10 consecutive days with subtherapeutic rilpivirine levels could be enough to result in viral rebound and resistance. 

GSK, J&J, Tivicay, Edurant, HIV, Dexcom, Fred's Pharmacy, Walgreens & Rite Aid sell 865 stores, Roche, Ocrevus, Biogen and Bioverativ make the highlights...